In a world prevalent with AIDS epidemic and Hepatitis B and C epidemics, accidental needle sticks and scalpel cuts have become a major concern to health-care workers. According to a study, the conversion rate for HIV positive needle sticks is 1 in 250 sticks. The conversion rate for scalpel cuts is unknown but according to a study of 10,000 health care workers, it is believed that the conversion rate is higher (as per U.S. Pat. No. 5,342,379). It is well known and understood by healthcare workers that sharp surgical instruments, such as scalpels, have a significant potential for harm to healthcare workers. The rapid handling of these sharp instruments can lead to accidental cuts or puncture wounds during surgery.
Thus, there is an inherent incentive for improvement in scalpel technology that can reduce and more ideally eradicate scalpel cuts to the health care worker. The chance of a healthcare worker contracting a fatal infection or disease because of an accidental scalpel cut comes with a heavy price on society and healthcare. The scalpel has not had many basic changes made in the past 100 years other than disposable blades and micro-surgical sizes.
Typically, most scalpel cuts or stabs occur in specific situations, such as a surgery. One occasion is at the time of passing a used scalpel to a scrub nurse. Another is when a surgeon swabs a bleeder and accidentally stabs himself (when he forgets that the scalpel is in his other hand). Trauma cases are another high risk situation in which an accidental laceration can occur because there many people simultaneously working on these cases and people are rushing to perform their tasks. Yet another case of accidental stabs is that if the blade sheath is lost or misplaced, the scalpel becomes dangerous for practically anyone and everyone in the proximity of the exposed scalpel blade. Another instance is during the disposal of medical waste, stabbing may occur because of accidental removal of the blade sheath. During the course of a surgery, the healthcare worker will usually remove the sheath and give the exposed scalpel blade to the doctor. Similarly after completion of the use of the scalpel, the surgeon may hand the exposed scalpel blade to the healthcare worker for covering. This process results in loss of time and may cause accidental stabbing of the healthcare worker or the surgeon. During waste disposal, the disposer is not always careful in handling the waste and may handle the waste roughly, which may result in removal of the sheath (if not already detached) and cause stabbing. This could also lead to spread of infection in the general public. Thus, there is a need to protect the healthcare workers from accidental scalpel stabs
To address this issue, in recent years, scalpels with disposable blade portions have been made. In this type of scalpel, the blade component is detachable from the handle component and disposed of by deposit in a special container. It will be appreciated, however, that such disposal of blades still presents a hazard to the individual who must detach and transfer the blade component.
Similarly, blade sheaths have been developed to cover the scalpel blade when the scalpel is not in use. While early blade sheaths did help reduce the potential for accidental cuts or puncture wounds, there were some problem areas. For example, safety scalpels are known that have a retractable external sheath, but they require two hands to operate. Some of the blade sheaths are awkward to operate. Others include complex mechanical mechanisms to move the sheath, which mechanisms could be prone to mechanical failure.
Attempts have been made to sheath the blade in the knife itself by providing a hollow handle component with a slidable blade therein. Basically, these instruments employ the handle component as a sheath for the blade component when not in use. Typically, such sheathable blade assemblies are not contemplated for disposal after a single use. Furthermore, such cutting instruments do not provide a positive means for preventing the unsheathing of the blade portion by a careless handler when disposal of the blade is desired.
Therefore, it is an object of the invention to provide a surgical scalpel assembly that reduces the complexity of prior known scalpel devices and which also provides additional safety and manufacturing benefits over known scalpel systems.